今天是:2020-04-08 星期三

黄芪汤治疗原发性胆汁性胆管炎中重度疲劳的临床评价和研究
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注册号:

Registration number:

ChiCTR2000031259 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

黄芪汤治疗原发性胆汁性胆管炎中重度疲劳的临床评价和研究 

Public title:

Clinical Evaluation and Study of Huangqi Decoction in Treating Severe Fatigue in Primary Biliary Cholangitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

黄芪汤治疗原发性胆汁性胆管炎中重度疲劳的临床评价和研究 

Scientific title:

Clinical Evaluation and Study of Huangqi Decoction in Treating Severe Fatigue in Primary Biliary Cholangitis 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

ChiMCTR2000003160 

申请注册联系人:

蒋式骊 

研究负责人:

蒋式骊 

Applicant:

Shili Jiang 

Study leader:

Shili Jiang 

申请注册联系人电话:

Applicant telephone:

+86 13917074505 

研究负责人电话:

Study leader's telephone:

+86 13917074505 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

jiangwhite@126.com 

研究负责人电子邮件:

Study leader's E-mail:

jiangwhite@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海浦东新区张衡路528号 

研究负责人通讯地址:

上海浦东新区张衡路528号 

Applicant address:

528 Zhangheng Road, Pudong New District, Shanghai, China  

Study leader's address:

528 Zhangheng Road, Pudong New District, Shanghai, China  

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海中医药大学附属曙光医院 

Applicant's institution:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019-778-131-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

IRB of Shuguang Hospital affiliated to Shanghai University of TCM  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-10 

伦理委员会联系人:

上海中医药大学附属曙光医院伦理委员会 

Contact Name of the ethic committee:

IRB of Shuguang Hospital affiliated to Shanghai University of TCM  

伦理委员会联系地址:

上海市浦东新区张衡路528号 曙光医院东部行政二楼 伦理委员会办公室  

Contact Address of the ethic committee:

Office of IRB, Second Floor, Eastern administration of Shuguang Hospital, 528 Zhangheng Road, Pudong District, Shanghai, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-20256070 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sgyyllwyh@126.com 

研究实施负责(组长)单位:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang Hospital affiliated to Shanghai University of TCM  

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号 

Primary sponsor's address:

528 Zhangheng Road, Pudong New District, Shanghai, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

具体地址:

浦东新区张衡路528号

Institution
hospital:

Shuguang Hospital affiliated with Shanghai University of TCM

Address:

528 Zhangheng Road, Pudong New District

经费或物资来源:

上海市科委“科技创新行动计划”临床医学领域科技支撑项目 

Source(s) of funding:

Science and Technology Innovation Project of Shanghai Science and Technology Commission  

研究疾病:

原发性胆汁性胆管炎 

Target disease:

Primary Biliary Cholangitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

通过对熊去氧胆酸加经典名方黄芪汤治疗原发性胆汁性胆管炎具有中重度疲劳患者的临床疗效的综合评估,分析生化学指标、疲劳自评量表与中医证候的相关性,明确黄芪汤的有效适应症,为难治性原发性胆汁性胆管炎的治疗提供临床依据,为临床应用提供指导性意见。 

Objectives of Study:

This project will comprehensively evaluate the clinical efficacy of ursodeoxycholic acid and the classic famous prescription Huangqi Decoction in the treatment of patients with primary bile cholangitis with moderate to severe fatigue, and analyze the correlation of biochemical indicators, fatigue self-assessment scale, and TCM syndromes, to clarify the effective indications of Huangqi Decoction, and provide clinical evidence and guidance for the treatment of refractory primary biliary cholangitis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄18-65岁,性别不限; (2)符合原发性胆汁性胆管炎诊断标准,即在排除病毒性肝炎的基础上,符合以下3项标准中的2项: ① 血清碱性磷酸酶(alkaline phosphatase, ALP)升高; ② 抗线粒体抗体(anti-mitochondrial antibody,AMA)和/或 AMA-M2 阳性; ③ 肝活检:非化脓性破坏性胆管炎及小叶间胆管破坏的组织学证据; (3)符合疲劳自评量表中重度评定标准; (4)病程≥1年; (5)本人或其监护人同意参加随机对照试验并签署知情同意书。 

Inclusion criteria

1. Ages 18-65 years, regardless of gender; 2. Meet the diagnostic criteria of primary bile cholangitis, that means, after excluding viral hepatitis, the patient must meet at least two of the following three criteria: (1) serum alkaline phosphatase (ALP) is elevated; (2) Anti-mitochondrial antibody (AMA) and / or AMA-M2 is positive; (3) liver biopsy: histological evidence of non-purulent destructive cholangitis and interlobular bile duct destruction 3. Comply with the moderate to severe assessment standards in the fatigue self-assessment scale; 4. Course of disease >= 1 year; 5. The subject or his guardian agrees enrolment in the randomized controlled trials and signs the informed consent. 

排除标准:

(1)研究者认为不适合入组的其它情况。 (2)因酒精、药物或者其他原因导致的肝脏疾病; (3)肝脏影像学提示大胆管梗阻; (4)合并严重心、肺、肾等脏器疾病者; (5)资料不全,影响有效性和安全性判断者; (6)合并自身免疫性肝炎患者; (7)依从性差者; (8)孕妇及哺乳期妇女; (9)有感染、大量顽固性腹水等终末期并发症者; (10)对中药黄芪、甘草和熊去氧胆酸过敏患者。 

Exclusion criteria:

1. Other conditions that the researcher consider not suitable for enrollment. 2. With liver disease caused by alcohol, drugs or other reasons; 3. Liver imaging suggests a large bile duct obstruction; 4. Patients with severe heart, lung, kidney and other organ diseases; 5. Incomplete information, which affects effectiveness and safety judgment; 6. Patients with combined autoimmune hepatitis; 7. Poor compliance; 8. Pregnant and lactating women; 9. Patients with end-stage complications such as infection and massive refractory ascites; 10. Patients who are allergic to Astragalus, Licorice and ursodeoxycholic acid. 

研究实施时间:

Study execute time:

From2020-05-01To 2022-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

39

Group:

experimental group

Sample size:

干预措施:

黄芪汤

干预措施代码:

Intervention:

Huangqi Decoction

Intervention code:

组别:

对照组

样本量:

39

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shuguang Hospital affiliated with Shanghai University of TCM  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

肝功能

指标类型:

主要指标 

Outcome:

liver function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

次要指标 

Outcome:

kidney function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

blood test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

次要指标 

Outcome:

urine test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能

指标类型:

次要指标 

Outcome:

Coagulation function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声

指标类型:

次要指标 

Outcome:

Ultrasound

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝脏瞬时弹性超声

指标类型:

次要指标 

Outcome:

Fibroscan

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由第三方使用统计软件产生随机号。

Randomization Procedure (please state who generates the random number sequence and by what method):

Random numbers are produced by third parties using statistical software.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验结束后公开,通过上传Excel/word文件共享到中国临床试验注册中心。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The original data will be revealed on the website of ResMan, Chinese Clinical Trail Registry after completion of the trial.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-26
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